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Olmesartan Pregnancy and Breastfeeding Warnings

Olmesartan is also known as: Benicar

Olmesartan Pregnancy Warnings

Olmesartan has been assigned to pregnancy category D by the FDA. Animal data have failed to reveal evidence of teratogenicity. There are no controlled data on olmesartan in human pregnancy. Drugs acting directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. Use of olmesartan is considered contraindicated during pregnancy.

Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered during pregnancy. Several dozen cases have been reported in the world literature in patients who were taking angiotensin converting enzyme (ACE) inhibitors. A committee of the National Institutes of Health has recommended that these drugs be avoided during pregnancy. When pregnancy is detected or expected, olmesartan should be discontinued as soon as possible. The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to exposure to the drug. These adverse effects do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester. Mothers whose embryos and fetuses are exposed to an angiotensin II receptor antagonist only during the first trimester should be informed. Nonetheless, when patients become pregnant, physicians should have the patient discontinue the use of olmesartan as soon as possible. Animal data have failed to reveal evidence of teratogenicity when olmesartan was given to pregnant rats at oral doses up to 1000 mg/kg/day and to pregnant rabbits at oral doses up to 1 mg/kg/day. However, significant decreases in fetal weight, pup birth weight, delays in developmental milestones, and dose-dependent increases in the incident of dilation of the renal pelvis were observed in studies in which parental rats were treated with olmesartan at doses of greater than 8 mg/kg/day.

Olmesartan Breastfeeding Warnings

There are no data on the excretion of olmesartan into human milk. Low concentrations are excreted into the milk of lactating rats. Due to the potential for serious adverse reactions in nursing infants, the manufacturer recommends that a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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